Curewave Lasers LLC MARCS-CMS 593692 — December 12, 2019

WARNING LETTER

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• Delivery Method: VIA UNITED PARCEL SERVICE
• Product: Medical Devices

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• Recipient: Daniel C. Herbert; Founder; Curewave Lasers LLC; 4101 Mcewen Rd, Suite 670; Dallas, TX 75244-5112; United States

• Issuing Office: Office of Medical Device and Radiological Health Operations (Division 3); United States

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WARNING LETTER
CMS: 593692

December 12, 2019

Dear Mr. Herbert:

During an inspection of your firm located in Dallas, Texas from August 22, 2019 to September 5, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Curewave Medicore. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that the Curewave Medicore device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

On May 18, 2017, your firm submitted a premarket notification, K171343, for the CureWave System, the CureWave Laser, and the CureWave Medicore. In a letter dated July 14, 2017, FDA advised you that the agency had determined the final classification of these devices to be Class II Exempt, under 21 CFR 890.5500, with a product code of ILY. This letter also stated that if you were to modify your device in the future by introducing either a new indication for use or a fundamental scientific technology different from that in the regulation, your device might exceed the limitations to the exemption and could consequently require 510(k) clearance prior to marketing this device in the United States. Devices under the ILY product code are intended to provide topical heating to the treatment area. However, evidence collected during our inspection demonstrates that your firm is marketing these devices with intended uses of “tissue regeneration”, “healing” and “improved vascular and cellular structural integrity.”

Additionally, a review of your firm’s websites (https://www.curewavelasers.com/, http://www.curewavelasers.com/doctors/, and http://www.curewavelasers.com/patients/) shows that you are marketing these devices with the following claims:

• The CureWave Laser is a proven and effective option for any person who prefers an effective alternative to drugs and borderline surgeries.
• The CureWave Laser technology is an advanced cutting edge technology revolutionizing the treatments for all soft tissue issues... and conditions as well as wound care.
• The major effects of the CureWaves Laser System include:
    o Enhanced Nerve Function
    o Quicker Wound Healing
    o Fights Bacterial Infection
    o Increase of Metabolic Activity
• CureWave Laser has successfully treated the following conditions demonstrating the lasers safety and efficacy:
    o Adhesive capsulitis (frozen shoulder)
    o Ankylosing spondylitis
    o Bactericidal effects
    o Buerger’s disease (thromboangiitis obliterans)
    o Cervical spine Cranial nerve VII (facial nerve) repair
    o Dental hypersensitivity
    o Diabetic neuropathy
    o Diabetic ulcers
    o Following dental surgery
    o Following neurosurgery
    o Hemangioma
    o Keloids
    o Nerve repair

None of these uses is included within the scope of the exemption from 510(k) notification for the above-referenced regulation.

Your firm has provided no evidence to FDA supporting the safety and efficacy of the CureWave laser devices as marketed on the websites listed above. The lack of evidence demonstrating the safety and efficacy of these claims raises public health concerns. Specifically, the risk for these devices, as advertised, is delay in definitive treatment. For example, delayed or ineffective treatment for wound care and bacterial infection can lead to loss of function, amputation, or death. Additionally, delayed or ineffective treatment for nerve damage can lead to permanent loss of function.

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency, per 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.

The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

Specifically, your firm has not established design control procedures. Your firm has not implemented your undated “Design & Development” procedure, DES/0100, revision 0. For example;

  a. Section 4.0-4.1.3 of your procedure states design inputs consist of identification and documentation of the requirements of the device under design. Form DES/0100-3: Design Input Checklist is to be used as an aid in assuring that no aspect of design input is overlooked. Form DES0100-4: Design Input Details is to be used to document design input specifications. Your firm did not document design inputs for the Curewave Medicore.

  b. Section 5.0-5.1.5 of your procedure states design outputs are to be documented on Form DES/0100- 4: Design Input Details and used to document that specifications have been met. The procedure goes on to state that the project manager will review and approve the design documentation through each design phase and at regularly scheduled design review meetings will assure the update of the design history file. Your firm did not identify/ document design outputs for the Curewave Medicore.

  c. Section 7.0 - 7.1.6 of your procedure states verification activities and tasks are completed throughout the design process. These activities are review, analysis, test, inspections, etc. and are listed in the DES/0100-4: Design Input Details. Your procedure goes on to state the design verification records will include a description of the methods (material, test, equipments, etc.) used, the results, the name(s) of the individual(s) completing the verification, and the date, recorded on form DES/0100-8: Design Verification Summary. Your firm performed various design activities including: an external skin temperature test using the Curewave Laser, skin test, laser fiber checks, etc. These design verification activities were not performed nor documented as per the design verification section 7.1.6.

• The “External skin temperatures using the curewave laser test”, dated June 21, 2016 indicates that safety tests for external skin temperatures using the CureWave laser at 30, 60, and 90 seconds were performed. The design verification activities do not include a protocol on how the test was performed, what equipment (including serial number) was used, or the name of the individual performing the test. The verification activities also do not establish an acceptance criteria prior to performing the test, nor does it interpret how the results of the tests were acceptable.

• The “Patient Skin Temperature with Various CW Treatment Areas and Patients” test indicates that skin temperatures were measured using a laser temperature reader. The test shows that the verification test was performed on 2 patients at various power settings for 60 seconds. The design verification activities do not include a protocol on how the test was performed, what equipment (including serial number) was used, or the name of the individual performing the test. The verification activities also do not establish an acceptance criteria prior to performing the test, nor does it interpret how the results of the tests were acceptable.

2. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).

Specifically, your firm has not established procedures for acceptance activities for your incoming components or finished products. For example,

You stated you conduct various power related tests using a fiber scope, power meter, and stopwatch on your subassemblies received from your contract manufacturer. However, you stated you do not have a written procedure describing these activities. Additionally, you stated you do not maintain records of the results of these activities, as required by 21 CFR 820.80(e).

3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example,

  a. Your firm has not implemented your undated “General Purchasing” procedure, PUR/0100, Rev. 0. For example, section 2.4 of your procedure states you will evaluate your suppliers yearly. However, you have not documented any evaluation of your laser diode and subassembly suppliers.

  b. Your firm has not implemented your undated “Vendor Assessment Procedure’, PUR/0200, Rev: 0. Your procedure states each vendor will be assessed in 3 areas on an annual basis and an assessment will be completed. However, your firm has not completed vendor assessments on your suppliers, contractors, and consultants.

  c. Your firm has not established agreements with your suppliers requiring them to notify you of changes to your purchased products and components which may affect the quality of your finished devices.

4. Failure to establish and maintain procedures to ensure that device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184.

Specifically, your firm has not established procedures for maintaining DHR’s for each batch, lot, or unit of products showing compliance with your device master record. Your firm has distributed 49 Curewave Medicore devices. You have not maintained DHRs for these devices which contain the date of manufacture, acceptance records, or primary identification labels.

In addition to being a “device”, the Curewave Medicore laser systems are “electronic products” subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, 1040.10, and 1040.11. Your firm failed to comply with the regulations regarding certification, product safety, reports, and recordkeeping.

5. Failure to certify, based on a test, in accordance with the standard, of the individual article to which the electronic product is attached, or upon a testing program which is in accordance with good manufacturing practices, as required by 21 CFR 1010.2(c). Specifically, your firm has not conducted a certification of its Class IV laser product based upon a test, in accordance with the standard, or testing program which is in accordance with good manufacturing practices. During the inspection, your firm acknowledged that it has not performed any tests (internally or externally) to certify the device as a Class IV laser.

6. Failure to incorporate in each Class IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body, having an error in measurement of no more than 20% when calibrated, as required by 21 CFR 1040.11(a)(1). Specifically, your firm manufactured and distributed a Class IV laser that emits 44 W at a wavelength of 1280 nm. Your firm did not incorporate a means for measuring the level of radiation in the laser product.

7. Failure to affix to each medical laser product, in close proximity to each aperture through which is emitted accessible laser radiation in excess of the accessible emission limits of Class I, a label bearing the wording: “Laser aperture”, as required by 21 CFR 1040.11(a)(3). Specifically, your firm manufactured and distributed laser products that did not have the “Laser aperture” label affixed.

8. Failure to provide the full name and address of the manufacturer of the product in a label, as required by 21 CFR 1010.3(a). The label shall be permanently affixed or inscribed on the product so as to be legible and readily accessible to view when the product is fully assembled for use. However, your firm has manufactured and distributed laser products and the following information was missing from the labels:

• Complete address of firm
• Month and year the device was manufactured

A review of your firm’s identification label revealed it contained only your firm’s name, city/state, website and sequential number.

9. Failure to submit a product report to the FDA/CDRH, prior to the introduction of a laser product into commerce, as required by 21 CFR 1002.10. For example, Curewave Lasers has manufactured and distributed 49 laser devices since 2017. However, FDA has not received initial product reports for these electronic products. FDA has also not received the subsequent annual reports, which are also required under 21 CFR 1002.13.

Section 538(a) of the Act, Subchapter C Electronic Product Radiation Control (EPRC), 21 U.S.C. § 360oo(a), prohibits any manufacturer from certifying or introducing into commerce electronic products which do not comply with an applicable standard. This section also prohibits any person from failing or refusing to establish and maintain required records or from failing to submit required notifications, reports, material, or information. Failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $375,000 without further notification by the FDA.

As it pertains to the EPRC failures to comply, you are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of referenced products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas. You have 15 days after you receive this letter to respond in writing using one of the options listed below:

I. Refutation - Under 21 CFR 1003.11(a)(3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.

II. Exemption Request - Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in Under 21 CFR 1003.10(b). If exempted from such notification, you are not required to correct the violative products (under 21 CFR 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31) and the information required under 21 CFR 1003.20.

III. Purchaser Notification and Corrective Action - If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.

a. Notification Letter - Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.

b. Corrective Action Plan (CAP) - Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the noncompliances and must be approved as set out in 21 CFR 1004.6.

As it pertains to the EPRC failures to comply, if you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11(c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.

Additionally, as it pertains to the EPRC failures to comply, you have the right to refute the findings in this letter by requesting a regulatory hearing before the FDA. However, a hearing is not required to respond to this letter with a refutation. Submission of your views and evidence to refute the alleged failures to comply as a written response, in accordance with option 1 above, is sufficient to assure your refutation will be evaluated. Information about requesting a regulatory hearing before FDA can be found in 21 CFR Part 16. A request for a regulatory hearing as described in 21 CFR §§ 16.22 and 1003.11(a)(3), must be submitted to FDA in writing within 15 days from receipt of this letter. Ensure that the packaging of your request for a regulatory hearing is clearly marked “APPEAL.” Send all materials related to a request for a regulatory hearing to:

CDRH-Ombudsman – OIR
Center for Devices and Radiological Health
Food and Drug Administration
WO32 Room 4282
10903 New Hampshire Avenue
Silver Spring, MD 20993

This notice of opportunity for hearing will not operate to delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner, as a matter of discretion, determines that delay or a stay is in the public interest (21 CFR § 16.22(d)).

When you have completed any production changes necessary to assure compliance of future units and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce.

Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm. FDA’s eSubmitter may be used to prepare reports: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.

We have reviewed your firm’s response, dated September 26, 2019, to the FDA-483, and determined it is not adequate. Your response states you have engaged a contractor to assist with the execution of corrective and preventive actions and to implement a complete quality system. However, the response does not include any details on your proposed corrective actions to allow us to evaluate the effectiveness of the changes. In response to this letter, please continue to provide updates to your corrective actions as well as supporting procedures and records to show completion and effectiveness of your ongoing actions.

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Also, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.

Your firm’s response should be sent to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at ORADevices3 FirmResponse@fda.hhs.gov. Please identify your response with FEI 1000125727.

In addition, please email your response (in PDF format) to: RadHealthCustomerService@fda.hhs.gov, copying the FDA/CDRH lead reviewer Sharon A. Miller (SharonA.Miller@fda.hhs.gov) and including the CDRH reference number EC190410/E001. If your response will be larger than 10MB, or you would prefer to mail a response, please address your response to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: Division of Radiological Health
Document Control Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

If you have any questions about the contents of this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251, or via e-mail at Jeffrey.wooley@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,
/S/

Binita Ashar, M.D., M.B.A., F.A.C.S.
Director
OHT4: Office of Surgical
    and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

/S/

Shari J. Shambaugh Program Division Director
Office of Medical Devices and Radiological
Health, Division III